Claims on plants obtained by essentially biological processes not excluded from patentability
Good news for the plant biotech industry: on March 25 2015 the Enlarged Board of Appeal (EBA) issued its ruling in the consolidated Broccoli (T83/05) and Tomato (T 1242/06) cases in favour of the patentability of claims on a novel plant product generated by an essentially biological process or a product-by-process claim defined in the terms of such a process.
The issue at stake in the referral has been the subject of a great deal of debate and controversy, and is of great interest to the plant biotech industry. In Cresco v Taste of Nature the District Court of The Hague decided not to wait for the referral and issued its ruling on May 8 2013, upholding the patentee's argument that a product claim formulated as obtainable by an essentially biological process should not be excluded from patentability under Article 53(b) of the European Patent Convention. Those in favour of a narrow reading of Article 53(b) allowing for claims on plant products obtained by essentially biological processes warned the EBA of the far-reaching consequences if it were to decide on a broad reading of Article 53(b) and consider a plant product obtainable by an essentially biological process not to be patentable. Those in favour of a broad reading – mostly united plant breeders – pleaded for a broad interpretation that would deny patent protection for newly developed plants, rendering them freely accessible for breeders.
The recently issued referral is not free standing but follows – and may even be the direct consequence – of the EBA's decision in the earlier consolidated referral in Broccoli and Tomato (G2/07 and G1/08). This focused on the scope of the legislative ambiguity of the wording “an essential biological process” of Article 53(b).
The original claims triggering the first referral in Broccoli related to a method of crossing and selection, wherein a molecular marker was used to assist in selecting the specific offspring. The original claims triggering the first referral in Tomato related to a method for crossing and selecting a tomato, wherein the method further comprised the step of allowing the fruit to remain on the vine in order to gain increased dry weight percentage. The debate over what was to be considered to be essentially biological in order to determine whether the claimed processes would be exempt from patentability triggered the first referrals in Broccoli and Tomato.
On December 9 2010 the EBA ruled that essentially biological processes of Article 53(b) encompassed not only the breeders' acts of sexually crossing whole plant genomes and subsequently selecting plants, but also further steps of technical nature which serve to enable or assist in these breeders' acts. It was indicated that such processes could escape from this exclusion only by comprising a further technical step which introduced or modified a trait in the genome of the produced plant via a mechanism other than via sexual crossing.
After issue of that decision, the patentees in both cases filed auxilliary requests based on product-by-(essentially biological) process claims. These raised new questions: if an essentially biological process claim was unallowable, would a product-by-(essentially biological) process claim be allowable or would this be considered as unallowable clever claim drafting in order to escape from the exclusion?
The Technical Board of Appeal referred questions to the EBA and both referrals were the subject of consolidated proceedings G2/13 and G2/12. Although phrased slightly differently, the questions of both referrals are highly similar. The questions of referral in G2/13 are copied below:
"1) Can the exclusion of essentially biological processes for the production of plants in Article 53(b) EPC have a negative effect on the allowability of a product claim directed to plants or plant material such as plant parts?
2) In particular:
a) is a product-by-process claim directed to plants or plant parts allowable if its process features define an essentially biological process for the production of plants?
b) is a claim directed to plants or plant material other than a plant variety allowable even if the only method available at the filing date for generating the claimed subject-matter is an essentially biological process for the prosecution of plants disclosed in the patent application?
3) Is it of relevance in the context of questions 1 and 2 that the protection conferred by the product claim encompasses the generation of the claimed product by means of an essentially biological process for the production of plants excluded as such under Article 53(b) EPC?
4) If a claim directed to plants or plant material other than a plant variety is considered not allowable because the plant product claim encompasses the generation of the claimed product by means of a process excluded from patentability under Article 53(b) EPC, is it possible to renounce on the protection for such generation by “disclaiming” the excluded process?"
Amicus curiae letters
Upon invitation by the EBA, many amicus curiae letters were sent, most of them stating that Article 53(b) should not be read extensively in that a product-by-(essentially biological) process is to be excluded from patentability. At least one letter clearly stated that the G1/07 and G2/08 decision was incorrect and should be reconsidered; the writer suggested that the reading of 'essentially biological processes' be restricted to processes of selection and crossing resulting in a plant variety. This would be an elegant solution, resulting in a fully compatible process and product exclusion of Article 53(b).
In contrast, united breeders (eg, Plantum, the European Seed Association and the German Plant Breeders Association) argued that allowing claims on products of essentially biological processes of producing plants would contravene the legislature's intention to prevent patents on all breeders' acts of crossing and selection, which would inevitably fall within the scope of such product claim.
On July 15 2014 the EBA filed a communication in order “to bring the legal issues into sharp focus”. The EBA made clear that the question at issue was a question only of law, rather than of economic or other, more general aspects. The EBA presented its intermediate conclusion that the wording, context, original legislative purpose and legislative history of Article 53(b) did not lead to an extensive reading. Further, it invited parties to discuss whether this intermediate conclusion needed further consideration as to its legal impact in the light of Article 32 of the Vienna Convention. Article 32 states that if the interpretation of law results in an “ambiguous or obscure” meaning or leads to a result which is “manifestly absurd or unreasonable”, supplementary means, such as the preparatory work of the treaty and the circumstances of its conclusion, should be taken into account.
The parties in Broccoli and Tomato (patent owners and opponents) filed written statements wherein they agreed to the EBA’s intermediate conclusion on the interpretation of Article 53(b) of the European Patent Convention and saw no need to apply Article 32 of the Vienna Convention as the EBA had already concluded that Article 53(b) was unambiguous and left no room to include products obtained by an essentially biological process. They further argued that a broad reading of Article 53(b) would result in the prohibition of patentability for almost everything in the plant area.
While the parties agreed with the EBA’s intermediate conclusion, the united plant breeders stated in amicus curiae letters that the intermediate conclusion of the EBA was wrong as the purpose of the legislature was not taken into account. This argument appears to be based on a different interpretation of the legislature’s intent with respect to the provision under debate. While the parties seemed to believe that the original intentions of Article 53(b) were to prevent the double protection of variants, which can be protected through the International Union for the Protection of New Varieties of Plants Convention, and to exempt non-technical (irreproducible) breeding processes, the united plant breeders seemed to be of the opinion that the true intention was the exclusion of the whole scope of plant breeding.
In its decision the EBA answered the abovementioned questions 1 and 2 in the negative and questions 2a and 2b in the affirmative. It further indicated that, as a result, question 4 did not require an answer. The decision clearly indicates that Article 53(b) reads on only process claims, not product claims. As long as a product claim on plants or plant material does not relate to a plant variety, such claim is not excluded from patentability and may even be formulated as a product obtainable by an essentially biological process. The decision is certainly good news for the plant biotech industry.
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